The Lancet :新型免疫药物可延长晚期肺癌患者生命
生物谷 · 2015/12/29
耶鲁大学领导的国际研究小组研究晚期非小细胞肺癌(NSCLC)患者对化疗的抗性,他们发现了一种通常用于治疗其它癌症的免疫治疗药物。这项研究结果发表在12月19日《柳叶刀》杂志上。


耶鲁大学领导的国际研究小组研究晚期非小细胞肺癌(NSCLC)患者对化疗的抗性,他们发现了一种通常用于治疗其它癌症的免疫治疗药物。这项研究结果发表在12月19日《柳叶刀》杂志上。

这项研究称为KEYNOTE010,比较单抗药物与化疗药物多西他赛在1034名非小细胞肺癌患者中表达PD-L1生物标志物的效果。PD-L1是许多肿瘤类型表达的一种蛋白质,可以使癌症逃离免疫攻击。该研究的统计分析点是总生存数(OS),无进展生存期(PFS),和安全性。

肿瘤患者的低水平表达可从单抗药物PD-L1中获益。平均下来,只要患者单独使用多西他赛(14.9个月和8.2个月) 两次,那么肿瘤患者就会表达最高量的PD-L1。耶鲁大学医学博士Roy S. Herbst说。

“我认为我们应该尽快用最好的药物治疗病人。现在我们已经了解了哪些病人最有可能受益于抗-PD-L1,我们可以开始在早前设置阶段转移这种药物。”Herbst说。“在这个方向我渴望看到正在进行的研究在一线设置中测试单抗的结果,并且作为一种佐剂希望在手术后减少肺癌的高复发率。”

在这项研究中,研究人员给予病人的药物经标准化疗后患者的肿瘤治疗有所进展。Herbst表示实验结果表明单抗可造成较少的明显的副作用,并且比化学疗法耐受。

2015年10月,美国食品和药物管理局授予加速批准单抗药物治疗转移性非小细胞肺癌(NSCLC)患者,在疾病进展时或在铂类化学疗法之后他们的肿瘤可表达PD-L1。

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  • Pembrolizumab versus docetaxel for previously treated, PD-L1-positive, advanced non-small-cell lung cancer (KEYNOTE-010): a randomised controlled trial

    Background Despite recent advances in the treatment of advanced non-small-cell lung cancer, there remains a need for effective treatments for progressive disease. We assessed the efficacy of pembrolizumab for patients with previously treated, PD-L1-positive, advanced non-small-cell lung cancer. Methods We did this randomised, open-label, phase 2/3 study at 202 academic medical centres in 24 countries. Patients with previously treated non-small-cell lung cancer with PD-L1 expression on at least 1% of tumour cells were randomly assigned (1:1:1) in blocks of six per stratum with an interactive voice-response system to receive pembrolizumab 2 mg/kg, pembrolizumab 10 mg/kg, or docetaxel 75 mg/m2 every 3 weeks. The primary endpoints were overall survival and progression-free survival both in the total population and in patients with PD-L1 expression on at least 50% of tumour cells. We used a threshold for significance of p<0·00825 (one-sided) for the analysis of overall survival and a threshold of p<0·001 for progression-free survival. This trial is registered at ClinicalTrials.gov, number NCT01905657. Findings Between Aug 28, 2013, and Feb 27, 2015, we enrolled 1034 patients: 345 allocated to pembrolizumab 2 mg/kg, 346 allocated to pembrolizumab 10 mg/kg, and 343 allocated to docetaxel. By Sept 30, 2015, 521 patients had died. In the total population, median overall survival was 10·4 months with pembrolizumab 2 mg/kg, 12·7 months with pembrolizumab 10 mg/kg, and 8·5 months with docetaxel. Overall survival was significantly longer for pembrolizumab 2 mg/kg versus docetaxel (hazard ratio [HR] 0·71, 95% CI 0·58–0·88; p=0·0008) and for pembrolizumab 10 mg/kg versus docetaxel (0·61, 0·49–0·75; p<0·0001). Median progression-free survival was 3·9 months with pembrolizumab 2 mg/kg, 4·0 months with pembrolizumab 10 mg/kg, and 4·0 months with docetaxel, with no significant difference for pembrolizumab 2 mg/kg versus docetaxel (0·88, 0·74–1·05; p=0·07) or for pembrolizumab 10 mg/kg versus docetaxel (HR 0·79, 95% CI 0·66–0·94; p=0·004). Among patients with at least 50% of tumour cells expressing PD-L1, overall survival was significantly longer with pembrolizumab 2 mg/kg than with docetaxel (median 14·9 months vs 8·2 months; HR 0·54, 95% CI 0·38–0·77; p=0·0002) and with pembrolizumab 10 mg/kg than with docetaxel (17·3 months vs 8·2 months; 0·50, 0·36–0·70; p<0·0001). Likewise, for this patient population, progression-free survival was significantly longer with pembrolizumab 2 mg/kg than with docetaxel (median 5·0 months vs 4·1 months; HR 0·59, 95% CI 0·44–0·78; p=0·0001) and with pembrolizumab 10 mg/kg than with docetaxel (5·2 months vs 4·1 months; 0·59, 0·45–0·78; p<0·0001). Grade 3–5 treatment-related adverse events were less common with pembrolizumab than with docetaxel (43 [13%] of 339 patients given 2 mg/kg, 55 [16%] of 343 given 10 mg/kg, and 109 [35%] of 309 given docetaxel). Interpretation Pembrolizumab prolongs overall survival and has a favourable benefit-to-risk profile in patients with previously treated, PD-L1-positive, advanced non-small-cell lung cancer. These data establish pembrolizumab as a new treatment option for this population and validate the use of PD-L1 selection. Funding Merck & Co.

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